Coral Drugs Pvt. Ltd. manufactures a wide range of high quality pharmaceutical ingredients. At Coral, we value the quality of our products above all else, which is demonstrated by regular audits of our factory as well as compliance with local and international regulatory governing authorities. Apart from our existing product line, Coral's R & D team is looking ahead to create multidimensional therapeutic products. Our purpose is to meet the medical needs of today.

International Business DevelopmentIdentification of countries to enter for API’sTo Maintain Good Relationship with customer’sMarket ResearchSelling company's internationally.Getting the requirements and sending the quotations to customers.Handling techno-commercial queries received from customer. Following up with the technical team internally and responding back to customerAbility to find the API customer in US &amp; EU market.Monitoring market changes in the targeted parts of the worldIncreasing brand awareness in target destinations

Preparation and compilation of DMF&nbsp;for&nbsp;US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.·&nbsp;Submission of technical data package and Applicant’s Part for semi-regulated markets·&nbsp;Submission of response to deficiencies received from authorities and customers·&nbsp;Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets·&nbsp;Use of eCTD software’s and submission gateways like ESG &amp; CESP·&nbsp;Providing regulatory inputs in early development phase of APIs·&nbsp;Review of change controls and technical data required for DMF submissions ·&nbsp;Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF ·&nbsp;Preparation of LOA and commitment and data management·&nbsp;Submission of change notification for customer.·&nbsp;Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps·&nbsp;Maintenance of database for regulatory submissions including customer notifications·&nbsp;Well versed with current regulatory guidelines.

Coral Drugs. Pvt. Ltd.